Status:
COMPLETED
Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI345
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
CLDN18.2 Positive Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
A phase Ia study to evaluate the safety, tolerance, pharmacokinetics and preliminary efficacy of IBI345 in patients with CLDN18.2 positive solid tumors
Eligibility Criteria
Inclusion
- Age ≥18 years and ≤75 years.
- Histologically or cytologically confirmed CLDN18.2 positive patients with advanced gastric cancer or pancreatic cancer who failed standard therapy .
- There are assessable lesions according to RECIST V1.1 (solid tumor efficacy evaluation criteria).
- Expected survival time ≥12 weeks.
- ECOG PS 0\~1.
Exclusion
- Participating in another interventional clinical study, other than observational (non-interventional) clinical study or in the survival follow-up phase of the interventional study.
- Received any antitumor drug within 2 weeks prior to apheresis or initial administration of the investigational drug.
- Use of immunosuppressive drugs within 1 week prior to apheresis or 2 weeks prior to initial administration of the investigational drug.
- Long-term systemic steroid or any other immunosuppressive drug therapy is required, not including inhaled steroid therapy.
- Receive live attenuated vaccine within 4 weeks prior to initial administration of the study drug or plan to receive live attenuated vaccine during the study period.
- Toxicity (excluding alopecia, fatigue, and hematological toxicity) that did not return to equal to or lower than Grade 1 of NCI CTCAE V5.0 from previous antitumor therapy prior to initial administration of the investigational drug.
Key Trial Info
Start Date :
December 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05199519
Start Date
December 13 2021
End Date
January 19 2023
Last Update
May 24 2023
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000